- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07330492
Testing a Brief Reassurance Message Before a Musculoskeletal Clinic Visit
Randomized Controlled Trial of a Nudge Intervention for Common Musculoskeletal Conditions
The goal of this clinical trial is to learn if a brief, reassuring pre-visit message affects patients' expectations and planned follow-up care in adults with common musculoskeletal conditions. The main questions it aims to answer are:
- Does reading a brief reassurance message before a clinic visit change how interested patients are in additional care, such as follow-up visits, tests, injections, or surgery?
- Does the message affect whether patients actually schedule follow-up care after the visit?
Researchers will compare participants who receive the pre-visit reassurance message to those who receive usual care to see if the message changes patients' enthusiasm for care or their follow-up decisions.
Participants will:
- Read a short, easy-to-understand message about musculoskeletal symptoms and options for care (for those in the intervention group)
- Complete a brief questionnaire rating their interest in follow-up visits, tests, injections, or surgery
- Have their scheduled follow-up care recorded after the clinic visit
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Ring, MD, PhD
- Phone Number: (833) 882-2737
- Email: david.ring@austin.utexas.edu
Study Locations
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-
Texas
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Austin, Texas, United States, 78712
- Musculoskeletal Institute, UT Health Austin
-
Contact:
- David Ring, MD, PhD
- Phone Number: (833) 882-2737
- Email: david.ring@austin.utexas.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult (18+ years)
- English or Spanish language literacy
- Seeking musculoskeletal specialty care
- Diagnosed with any non-traumatic musculoskeletal condition
- New or return patient to clinic
Exclusion Criteria:
- Cognitive or other impairment precluding completion of a survey on a tablet
- Acute traumatic pathophysiology (fracture, dislocation, sprain/strain)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm (Nudge / Reassurance Message)
Participants randomized to the intervention group will read a brief, easy-to-understand message (generated by a Large Language Model) before their musculoskeletal clinic visit.
The message explains that many musculoskeletal symptoms are common, often related to normal body changes, and can improve with simple self-care.
It emphasizes that visits, tests, injections, and treatments are often optional, and patients can decide how much care they wish to pursue.
After reading the message, participants will complete a short questionnaire rating their interest in follow-up visits, tests, injections, and surgery.
Clinicians providing care will be blinded to participants' group assignment.
|
The intervention involves reading a brief, easy-to-understand message prior to a musculoskeletal clinic visit.
The message explains that many musculoskeletal symptoms are common, often related to normal age-related changes, and can improve with simple self-care.
It emphasizes that visits, tests, injections, and treatments are often optional, and patients can choose how much care to pursue.
Other Names:
|
|
No Intervention: Control arm (Usual Care)
Participants randomized to the control group will receive usual care prior to their musculoskeletal clinic visit, without any pre-visit reassurance message.
They will complete the same questionnaire rating their interest in follow-up visits, tests, injections, and surgery.
Clinicians providing care will be blinded to participants' group assignment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-visit enthusiasm for additional care
Time Frame: Immediately after intervention
|
The primary outcome is pre-visit enthusiasm for additional care, measured as participants' self-reported interest in pursuing a return visit, diagnostic tests, physical therapy, injections, or surgery.
Participants rate each item on a 0-10 scale, where 0 indicates "not at all interested" and 10 indicates "definitely want it."
This outcome is assessed immediately after the intervention (or usual care) and before the clinic visit.
|
Immediately after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Actual scheduled follow-up care
Time Frame: Immediately following clinic visit
|
The secondary outcomes are actual scheduled follow-up care after the musculoskeletal clinic visit, including return visits, diagnostic tests, physical therapy, injections, and surgery.
These outcomes are recorded as yes/no for each type of care and are collected from the patient's medical record after the visit.
|
Immediately following clinic visit
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004831.3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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